Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance
Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulae because a foreign substance was found on the inner surface of some tips that could be dislodged.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a potential for harm (dislodged foreign substance) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling the Sarns Antegrade Cardioplegia Cannula, part of the XC HEART/LUNG PACK W/SX25RX. The recall involves 53,139 units distributed worldwide, including nationwide in the United States and in various international countries.
During production, Terumo CVS identified a foreign substance on the inner surface of some cannulae tips. A preliminary investigation determined that this substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, though its exact composition is not specified in the source text.
The affected products are identified by Catalog number 71415-04 and lot number NN07. These devices are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, vent the left heart, and aspirate air from the aorta during cardiopulmonary bypass procedures. Users should stop using the affected units and contact the manufacturer for instructions.
The recalled product
- Product
- XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during c
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Affected units
- 53,139
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog number: 71415-04 and lot number: NN07
Distribution
Part of a larger recall action
This product is one of 20 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 20 products in this recall →Related recalls
Same manufacturer · Terumo Cardiovascular Systems Corporation
See all →- HighCDI OneView System BPM Probe temperature sensor measurement inaccuracy
FDA (Devices) · 2025-07-02
- HighTerumo CDI OneView Monitor Probe May Fail to Display Oxygen Saturation Data
FDA (Devices) · 2025-04-09
- HighCardiovascular Procedure Kits Recalled for Pressure Relief Valve Defect
FDA (Devices) · 2024-04-10
- HighCAPIOX FX25 Oxygenator Recalled for Potential Leaks from Improper Bonding
FDA (Devices) · 2023-04-12
- HighTerumo Recalls CAPIOX NX19 Oxygenator Due to Improper Bonding
FDA (Devices) · 2023-04-12
Same hazard · foreign object
See all →- SevereOutshine Strawberry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Black Cherry Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Fruit Bars Grape Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02
- SevereOutshine Watermelon Fruit Bars Recalled for Potential Glass Contamination
FDA (Food) · 2026-09-02